The following information is taken in part from FDA's website on implants.

Signing a consent form is now part of the procedure for all women undergoing breast implant surgery. They must also be given information about the devices' known and possible risks:

General surgical risks:

• possible complications of general anesthesia, as well as nausea, vomiting and fever
• infection
• hematoma (collection of blood that may cause swelling, pain and bruising, perhaps requiring surgical draining)
• hemorrhage (abnormal bleeding)
• thrombosis (abnormal clotting)
• skin necrosis--skin tissue death resulting from insufficient blood flow to the skin. The chance of skin necrosis may be increased by cortisone-like drugs, an implant too large for the available space, or smoking.

I discuss various surgical risks in greater details on my pages on potential complications from plastic surgery and SRS.

Specific implant risks

Capsular contracture

When any type of breast implant is inserted, the body reacts by forming a protective lining around it. This is referred to as the "capsule" or "tissue capsule." Some people refer to it as the "scar capsule" although it is not exactly the same as scar tissue. The capsule is formed by your own living tissue. It is normal and happens in everyone regardless of whether the implant is smooth or textured, silicone or saline.

According to various studies, the risk of this is anywhere from 5 to 50%. that's a lot. In all implant operations, apparently, your body's immune system forms a "capsule" around the implant to protect itself from this foreign body.

In some women, for reasons we don't understand completely, the capsule has a tendency to shrink, squeezing the implant. This is referred to as capsular contracture. The tighter the capsule becomes the firmer the breast feels. A plastic surgeon named Baker divided capsular contracture into four stages:

• Baker grade I means the breast looks and feels soft (there is a capsule but it is not contracted);
• Baker grade II means the breast looks normal but feels somewhat firm (there is mild to moderate contracture of the capsule);
• Baker grade III means the breast not only feels firm but is beginning to be distorted by the contracture, meaning it has begun to take on an abnormally round shape, like a ball, or the implant is being squeezed out of normal position, usually upward;
• Baker grade IV is the same as III but with the addition of pain caused by the progressive tightening of the capsule. No matter the degree of capsular contracture, it is not the implant that gets hard. If the implant is removed it is as soft as when it was inserted. It is the interaction of the capsule with the implant that can make the breast feel firm. Capsular contracture alone does not cause implant rupture because the force is exerted evenly around the surface of the implant.

Some doctors may try treating capsular contracture with Vitamin E or antibiotics, depending on what they view as the cause of the contracture, but medical therapy is rarely successful. Another treatment is called "closed capsulotomy." In this technique, the doctor forcefully squeezes the breast in an attempt to cause the capsule surrounding the implant to "pop" or tear. There are some risks to this procedure and most doctors are reluctant to do it because of medicolegal concerns and possible violation of the implant warranty.

The treatment of capsular contracture is usually surgical. In an "open capsulotomy" the surgeon scores, or cuts, the capsule to release its hold on the implant. In an "open capsulectomy," the entire capsule is surgically removed. The body then forms a new capsule but the hope is that it does not contract as the old one did. Capsulectomy is a more extensive operation than capsulotomy but has a higher rate of success in correcting contracture. Only a relatively small percentage of women with implants develop capsular contracture severe enough to require surgical treatment. The rare patient develops repeated capsular contracture but in the majority of cases it can be successfully treated.

Leak or rupture

This is another common occurrence, and the odds increase each year postoperatively.

Saline implants may rupture suddenly and deflate, usually requiring immediate removal or replacement. Valves can leak and the implants have to be removed. That can mean more surgery, more scar tissue and thousands of dollars more in expense.

Breast implants can last anywhere from a few years to a few decades, with most making it at least to 10-15 years without problems. However, the younger you do it, the more likely you'll need additional surgeries over the course of your life.

A friend of mine was watching TV on her couch when one of hers just ruptured. She watched it go right down. She ended up getting the other one taken out when she had the empty shell removed.

 

Change or loss of sensation

This can occur in the nipple or breast tissue, and can be temporary following surgery, or permanent. In my own case, my right nipple is more sensitive, and my left one is less sensitive.

Calcium deposits

These can form near the implant, possibly causing pain and hardening.

Interference with mammography readings

Implants can delay breast cancer detection by "hiding" a suspicious lesion. Also, it may be difficult to distinguish calcium deposits formed in the scar tissue from a tumor when interpreting the mammogram. When making an appointment for a mammogram, the woman should tell the scheduler she has implants to make sure qualified personnel are on-site. At the time of the mammogram she should also remind the technician she has implants before the procedure is done, so the technician can use special techniques to obtain the best mammogram and to avoid rupturing the implant.

If they are placed below the muscle, you have a much better chance of having a minimally obstructed mammogram if you go to a specialist in implant mammography and tell them you have implants. A new implant, the soy bean oil implant is not obstructive in mammography but appears on the mammography film much like regular breast tissue.

Autoimmune-like disorders*

Signs include joint pain and swelling; skin tightness, redness or swelling; swelling of hands and feet; rash; swollen glands or lymph nodes; unusual fatigue; general aching; greater chance of getting colds, viruses and flu; unusual hair loss; memory problems; headaches; muscle weakness or burning; nausea or vomiting; and irritable bowel syndrome.

Recent studies have shown, however, that there is not a large increased risk of traditional autoimmune, or connective tissue disease, from silicone gel implants.

Fibrositis/fibromyalgia-like disorders*

(pain, tenderness and stiffness of muscles, tendons and ligaments).

* while some women have reported these disorders, studies have been inconclusive as to the relationship between implants and these problems.

Potential cosmetic problems

Too big or too small

Poor choice of size can prevent you from getting the desired effect. Some TS women go too big, which can actually draw attention, look unnatural, and hinder your ability to pass. Craefully discuss your size with your surgeon.

Nipple placement

It's not uncommon for TS women to have nipples pointing slighly outward, probably due to our larger ribcages. Implants placed to high or low in a pocket can also make nipples seem unnatural.

Rippling

This is more of a cosmetic risk. If any of you have every seen a bad X-rated or soft porn movie with actresses whose implants are a little too big, you may have seen this phenomenon.

Rippling looks like someone had their fingers on the breast and left indentations. It is not a permanent rippling in most cases but a ripple occasionally as the implant moves and literally ripples, giving the skin a wave-like appearance instead of the smoothness you see in a normal breast.

It is in the nature of saline inflatable implants to have wrinkling of the shell. This is because the shell needs to be thick and strong enough to last as long as possible, and because the saline (salt water) fill shifts with changes in body position. The rippling is most objectionable when it is visible at the top of the breast. For that reason, placing implants beneath the large pectoral muscle can be particularly advantageous with saline implants. The thickness of the muscle obscures whatever wrinkling there might be, in the same way that a thick carpet will hide uneven floor boards.

The other thing that the surgeon can do to minimize wrinkling is to always fill the implant more than the minimum specified by the manufacture, while not exceeding the maximum – in other words, filling to a "happy medium."

Movement or shifting

Sometimes the implant doesn't sit in the surgically-formed pocket right. This can be due to capsular contracture or other complications. Sometimes the pocket itself is not shaped right or is too big or small. This can cause the implant to move from the original placement (frequently upward), giving the breast an unnatural look.

Plan on needing new ones in 10 years

A September 22 2002 syndicated article noted the likelihood of complications:

The most recent data presented to the FDA showed, for instance, that almost one-quarter of all cosmetic saline, or saltwater-filled, breast implants will need to be followed by another operation within five years, and that few implants can be expected to last more than 10 years. Studies have also found significant levels of internal infection, hardening of the tissue around the implanted device and implant leakage and deflation.

"This is a cosmetic operation with serious health consequences, and the FDA is just not treating it with the seriousness it requires," said Diana Zuckerman, president of the National Center for Policy Research for Women and Families and a longtime critic of the breast implant industry. "The benefits are so small compared to the very real risks, so it should be getting more scrutiny, not less."